S A Hurvitz1, R G W Quek2, N C Turner3, M L Telli4, H S Rugo5, A Mailliez6, J Ettl7, E Grischke8, L A Mina9, J Balmaña10, P A Fasching11, H Bhattacharyya12, A L Hannah13, M E Robson14, A M Wardley15. 1. University of California, Los Angeles, 10945 Le Conte Avenue PVUB 3360, Los Angeles, CA, 90095, USA. Electronic address: SHurvitz@mednet.ucla.edu. 2. Pfizer Inc., 525 Market Street, 36th Floor, San Francisco, CA, 94105, USA. Electronic address: Ruben.Quek@pfizer.com. 3. The Royal Marsden Hospital-The Royal Marsden NHS Foundation Trust, Fulham Road, Chelsea, London, SW3 6JJ, UK. Electronic address: Nicholas.Turner@icr.ac.uk. 4. Stanford University School of Medicine, 900 Blake Wilbur Drive, 1st Floor, Palo Alto, CA, 94304, USA. Electronic address: mtelli@stanford.edu. 5. University of California San Francisco Comprehensive Cancer Center, 1600 Divisadero Street, 3rd Floor, San Francisco, CA, 94115, USA. Electronic address: Hope.Rugo@ucsf.edu. 6. Centre Oscar Lambret, 3 Rue Frédéric Combemale, 59000, Lille, France. Electronic address: a-mailliez@o-lambret.fr. 7. Klinikum Rechts der Isar, Technische Universität München, Ismaningerstrasse 22, 81675, Munich, Germany. Electronic address: johannes.ettl@tum.de. 8. Universitäts-Frauenklinik Calwerstr. 7, 72076, Tübingen, Germany; Eberhard Karls University, Geschwister-Scholl-Platz, 72074, Tübingen, Germany. Electronic address: eva-maria.grischke@med.uni-tuebingen.de. 9. Banner MD Anderson Cancer Center, 2946 E Banner Gateway Dr, Gilbert, AZ, 85234, USA. Electronic address: Lida.Mina@bannerhealth.com. 10. Hospital Vall d'Hebron, Vall d'Hebron Institute of Oncology, CELLEX CENTER, C/ Natzaret, 115-117, 08035, Barcelona, Spain. Electronic address: jbalmana@vhio.net. 11. University Hospital Erlangen, Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Universitätsstraße 21-23, 91054 Erlangen Erlangen, Germany. Electronic address: Peter.Fasching@uk-erlangen.de. 12. Pfizer Inc., 525 Market Street, 36th Floor, San Francisco, CA, 94105, USA. Electronic address: Helen.Bhattacharyya@pfizer.com. 13. Pfizer Inc., 525 Market Street, 36th Floor, San Francisco, CA, 94105, USA. Electronic address: Alison.Hannah@pfizer.com. 14. Memorial Sloan Kettering Cancer Center, 1275 York Ave, New York, NY, 10065, USA. Electronic address: robsonm@mskcc.org. 15. The NIHR Manchester Clinical Research Facility at The Christie & Division of Cancer Sciences University of Manchester, Manchester Academic Health Science Centre, Manchester, UK. Electronic address: Andrew.Wardley@christie.nhs.uk.
Abstract
BACKGROUND: Talazoparib (1 mg/day) exhibited promising efficacy and safety in patients with advanced breast cancer during ABRAZO (NCT02034916); this study evaluated patient-reported outcomes (PROs). PATIENTS AND METHODS: ABRAZO is a two-cohort, two-stage, phase 2 study of talazoparib in patients with advanced breast cancer after a response to prior platinum-based therapy (cohort 1 [C1], n = 49) or ≥3 platinum-free cytotoxic-based regimens (cohort 2 [C2], n = 35). PROs were assessed on day 1 (baseline), every 6 weeks for an initial 24 weeks, and every 12 weeks thereafter until progression, using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) and its breast cancer module, QLQ-BR23. RESULTS: Global health status/quality of life (GHS/QoL) was maintained from baseline across all time points for both C1 and C2. For C1 and C2, median time to deterioration (TTD) of GHS/QoL (95% confidence interval [CI]) was 2.8 (2.1, 3.0) and 5.5 (4.2, 5.7) months, respectively. Median TTD for all QLQ-C30 functional scales for C1 and C2 ranged 2.1-3.1 months and 4.2-5.6 months, respectively; median TTD for all QLQ-BR23 symptom scales ranged 2.6-4.0 months and 4.2-5.6 months, respectively. There were no statistically significant differences in estimated overall change from baseline in the GHS/QoL scale for both cohorts (C1: -2.6 [95% CI, -7.8, 2.5]; C2: 1.2 [95% CI, -5.5, 8.0]). Significant overall improvements in the breast symptoms and arm symptoms and the future perspective of patients in C1 and C2 were observed, despite the statistically significant and clinically meaningful overall deterioration among patients regarding their role functioning (in C1) and dyspnoea symptoms (in C2). CONCLUSION: Despite the statistically significant and clinically meaningful overall deterioration among patients regarding their role functioning (in C1) and dyspnoea symptoms (in C2), patients in both C1 and C2 reported significant overall improvements in their breast symptoms, arm symptoms and future perspective, and their GHS/QoL was maintained from baseline. Published by Elsevier Ltd.
BACKGROUND:Talazoparib (1 mg/day) exhibited promising efficacy and safety in patients with advanced breast cancer during ABRAZO (NCT02034916); this study evaluated patient-reported outcomes (PROs). PATIENTS AND METHODS: ABRAZO is a two-cohort, two-stage, phase 2 study of talazoparib in patients with advanced breast cancer after a response to prior platinum-based therapy (cohort 1 [C1], n = 49) or ≥3 platinum-free cytotoxic-based regimens (cohort 2 [C2], n = 35). PROs were assessed on day 1 (baseline), every 6 weeks for an initial 24 weeks, and every 12 weeks thereafter until progression, using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) and its breast cancer module, QLQ-BR23. RESULTS: Global health status/quality of life (GHS/QoL) was maintained from baseline across all time points for both C1 and C2. For C1 and C2, median time to deterioration (TTD) of GHS/QoL (95% confidence interval [CI]) was 2.8 (2.1, 3.0) and 5.5 (4.2, 5.7) months, respectively. Median TTD for all QLQ-C30 functional scales for C1 and C2 ranged 2.1-3.1 months and 4.2-5.6 months, respectively; median TTD for all QLQ-BR23 symptom scales ranged 2.6-4.0 months and 4.2-5.6 months, respectively. There were no statistically significant differences in estimated overall change from baseline in the GHS/QoL scale for both cohorts (C1: -2.6 [95% CI, -7.8, 2.5]; C2: 1.2 [95% CI, -5.5, 8.0]). Significant overall improvements in the breast symptoms and arm symptoms and the future perspective of patients in C1 and C2 were observed, despite the statistically significant and clinically meaningful overall deterioration among patients regarding their role functioning (in C1) and dyspnoea symptoms (in C2). CONCLUSION: Despite the statistically significant and clinically meaningful overall deterioration among patients regarding their role functioning (in C1) and dyspnoea symptoms (in C2), patients in both C1 and C2 reported significant overall improvements in their breast symptoms, arm symptoms and future perspective, and their GHS/QoL was maintained from baseline. Published by Elsevier Ltd.
Entities:
Keywords:
BRCA1; BRCA2; Breast cancer; Patient-reported outcomes; Poly (ADP-Ribose) polymerase; Quality of life; Talazoparib
Authors: Yolanda Jerez; Ivan Márquez-Rodas; Inmaculada Aparicio; Manuel Alva; Miguel Martín; Sara López-Tarruella Journal: Drugs Date: 2020-02 Impact factor: 9.546